I've had three distinct careers: biomedical scientist; FDA drug regulator; and scholar at the Hoover Institution, a think-tank at Stanford University. During the first of these, I worked on various aspects of gene expression and regulation in viruses and mammalian cells. I was the co-discoverer of a critical enzyme in the influenza (flu) virus. While at the FDA, I was the medical reviewer for the first genetically engineered drugs and thus instrumental in the rapid licensing of human insulin and human growth hormone. Thereafter, I was a special assistant to the FDA commissioner and the founding director of the FDA's Office of Biotechnology. Since coming to the Hoover Institution, I have become well known for both contributions to peer-reviewed scholarly journals and for articles and books that make science, medicine, and technology accessible to non-experts. I have written four books and about 2,000 articles. I appear regularly on various nationally syndicated radio programs. My most frequent topics include genetic engineering, pharmaceutical development, and the debunking of various manifestions of junk science.

The Obama Administration's Transparent Lack Of Transparency

“How can you tell when a politician is lying,” an old quip begins. “His lips are moving.” This whopper for the ages from President Obama is getting a lot of attention: “No matter how we reform health care, we will keep this promise to the American people: If you like your doctor, you will be able to keep your doctor. Period. If you like your health care plan, you will be able to keep your health care plan. Period.”

It turns out that under ObamaCare, these oft-repeated, unequivocal assurances do not apply to as many as 12 million Americans.

The president has gone those outright lies one better by managing to mislead the American people even when his lips are motionless, a virtuoso performance of political ventriloquism. In spite of the president’s promise that his administration would be the most transparent in history, on matters big and small his minions constantly misrepresent, misbehave and betray our trust.

High-profile examples include the stonewalling over the Benghazi murder of four Americans, including the U.S. ambassador, and the broken promises about ObamaCare. But there are plenty of other examples of gross malfeasance and mendacity by the Obama administration that are occurring largely out of the public eye.

One that has received attention lately from Sen. David Vitter and other Republicans on the Environment and Public Works Committee is the “sue and settle” maneuver that federal agencies, including the Fish and Wildlife Service and EPA, use to advance their radical environmental agenda in a way that substitutes a judicial mechanism for the customary interface of legislation and agency rulemaking. The way this works is that extremist environmental groups (some of which receive government grants) sue the federal government on the grounds that agencies are failing to meet their regulatory obligations, and then, behind closed doors, the activists and Obama administration officials concoct a settlement agreement that furthers activists’ (and regulators’) radical goals.

This process is typically pursued without consulting affected parties, including states, counties and municipalities that are the sites of the alleged deficiencies of regulation. Once a judge approves a settlement, the administration moves forward with implementing costly regulations that resulted from “wink-wink, nod-nod” negotiations between activist environmental groups and the government. According to Sen. Vitter, “Of the 250 species listings that could occur as a result of the 2011 closed-door settlements, many could have a significant impact on states and local governments, private property rights, energy development, and economic growth.”

Leaving aside the merits of these agreements, they are arrived at via a flagrantly non-transparent process that evades the checks and balances of federal rulemaking and oversight.

Another exemplar of the administration’s lack of transparency involves the irregular oversight applied to a genetically altered fish that has been treading water in regulatory limbo for years.

The only new characteristic that distinguishes the “AquAdvantage” salmon from its wild cohorts is that it reaches maturity twice as rapidly. Its genetic changes – the insertion into the genome of a growth hormone gene from the Chinook salmon and a regulatory DNA sequence from the ocean pout — confer no detectable difference in the fish’s appearance, ultimate size, taste or nutritional value; it just grows faster, a tremendous economic advantage to those farming the fish in a closed water system. Its availability would also be a tremendous boon to consumers seeking low-fat and affordable options for sources of protein, especially in the face of food price inflation and the obesity epidemic.

After almost 13 years of floundering over how to review this fish, in 2009 the FDA opted for the most stringent, expensive and dilatory regulatory approach among various possible policy choices. The FDA’s Center for Veterinary Medicine chose to subject genetically engineered animals to the same burdensome pre-market approval procedures and regulations as veterinary drugs such as pain relievers and anti-flea medicines. The rationale was that the new DNA construct in the animal and any proteins it produces are analogous to drugs that have been injected or ingested — even though animals with identical traits introduced by techniques such as breeding or artificial insemination would not be subject to any premarket review at all.

A more apposite and far less burdensome regulatory paradigm for animals used as food would be the approach taken by another FDA unit, the Center for Food Safety and Nutrition, whose policies put the burden of ensuring the safety of foods and food ingredients on those who produce them. Its regulations prohibit the adulteration (contamination) or misbranding (mislabeling) of food, but the agency does not inspect or evaluate every new food prior to its sale in shops, supermarkets, or restaurants. Rather, federal oversight relies primarily on market surveillance and post-marketing regulation, and the FDA takes action if there is an apparent problem. This approach has worked quite well over many years.

The law does require a premarketing safety review for certain food-related products judged to be higher-risk. These include most food additives — a class of ingredients that includes preservatives, emulsifiers, spices, sweeteners, and natural and synthetic flavors and colors, among others. In general, a food additive must be pre-approved if it will become a component of or otherwise affect the characteristics of a food and if it is “not generally recognized as safe (GRAS) by qualified experts for its intended use.” (The AquAdvantage salmon would be GRAS.)

If the FDA had applied the food-regulation paradigm to genetically engineered animals at the outset, the fast-maturing salmon would have been on our dinner plates during the Clinton administration.

Not surprisingly, the FDA’s several years-long evaluation concluded that the AquAdvantage salmon has no detectable differences and that it “is as safe as food from conventional Atlantic salmon.” And because the fish will all be sterile females and farmed inland, there is negligible possibility of any sort of “genetic contamination” of the gene pool or other environmental effects. Even in a worst-case scenario, these fish would be maladapted to compete in the wild.

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